Recall archive / FDA device enforcement

Model Number L111, ESSENTIO DR SL MRI Pacemaker — FDA record Z-0095-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 20, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Model Number L111, ESSENTIO DR SL MRI Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Classification: Class I
Recalling firm: Boston Scientific Corporation
Quantity: 223,163 units
Agency-reported status: Ongoing
Source record identifier: Z-0095-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	GTIN 00802526559228, Serial numbers: 103410, 200337, 200359, 200704, 201273, 201585, 202131, 203086, 204240, 204255, 204383, 204472, 204532, 204553, 204558, 204581, 204619, 204644, 204658, 204672, 204680, 204704, 204729, 204735, 204748, 204768, 204779, 204855, 204883, 204891, 204907, 204916, 204929, 204934, 204947, 204951, 204957, 204959, 204968, 204985, 205002, 205044, 205073, 205083, 205105, 205130, 205149, 205192, 205199, 205211, 205227, 205233, 205236, 205290, 205360, 205362, 205363, 205408, 205412, 205413, 205415, 205455, 205480, 205543, 205553, 205560, 205585, 205586, 205587, 205625, 205632, 205636, 205672, 205673, 205686, 205688, 205733, 205742, 205767, 205770, 205773, 205782, 205791, 205796, 205797, 205810, 205854, 205855, 205857, 205861, 205863, 205907, 205911, 205920, 205940, 205945, 205946, 205958, 205961, 205965, 205967, 205971, 205975, 205977, 205979, 205989, 205992, 205997, 205998, 206011, 206019, 206033, 206045, 206046, 206049, 206069, 206070, 206074, 206075, 206080, 206090, 206091, 206092, 206095, 206098, 206112, 206115, 206122, 206129, 206138, 206140, 206142, 206146, 206167, 206175, 206184, 206190, 206192, 206195, 206200, 206217, 206219, 206220, 206222, 206225, 206226, 206230, 206233, 206244, 206255, 206263, 206277, 206287, 206294, 206295, 206297, 206299, 206300, 206318, 206320, 206326, 206333, 206342, 206343, 206346, 206373, 206407, 206412, 206415, 206437, 206458, 206473, 206502, 206509, 206533, 206541, 206548, 206551, 206556, 206578, 206699, 206762, 206855, 206959, 207311, 207987, 208185, 208473, 208694, 208876, 209013, 209266, 209386, 209388, 209463, 209618, 209752, 209830, 209963, 210013, 210023, 210032, 210044, 210078, 210177, 210192, 210211, 210252, 210338, 210390, 210401, 210493, 210500, 210570, 210685, 210730, 210744, 210773, 210780, 210787, 210814, 210852, 210874, 210917, 210928, 210989, 211000, 211051, 211073, 211099, 211107, 211150, 211157, 211199, 211258, 211266, 211271, 211290, 211333, 211351, 211364, 211401, 211404, 211409, 211415, 211466, 211493, 211496, 211521, 211536, 211544, 211560, 211578, 211658, 211659, 211694, 211697, 211735, 211794, 211806, 211816, 211838, 211842, 211860, 211863, 211899, 211901, 211908, 211937, 211941, 211944, 211958, 211963, 211964, 211966, 211976, 211977, 211983, 211984, 211987, 212013, 212035, 212039, 212051, 212059, 212060, 212062, 212068, 212071, 212077, 212079, 212080, 212087, 212088, 212091, 212101, 212107, 212128, 212131, 212136, 212138, 212148, 212149, 212165, 212168, 212179, 212182, 212184, 212190, 212192, 212193, 212198, 212201, 212207, 212221, 212248, 212255, 212261, 212283, 212470, 212556, 212562, 212640, 212796, 212857, 212937, 213150, 213153, 213166, 213173, 213217, 213242, 213326, 213361, 213362, 213370, 213382, 213399, 213490, 213501, 213512, 213522, 213567, 213634, 213663, 213700, 213739, 216402, 216680, 216880, 217526, 217806, 218042, 218214, 218459, 218609, 218658, 218692, 218767, 218857, 218926, 218967, 219037, 219178, 219207, 219463, 219522, 219580, 219645, 219663, 219681, 219688, 219701, 219706, 219711, 219721, 219722, 219731, 219748, 219756, 219757, 219782, 219786, 219802, 219822, 219835, 219843, 219844, 219852, 219863, 219873, 219881, 219888, 219889, 219894, 219897, 219920, 219924, 219932, 219936, 219937, 219940, 219955, 219958, 219961, 219967, 219971, 219972, 219976, 219980, 219988, 219997, 220002, 220009, 220010, 220013, 220015, 220016, 220018, 220019, 220021, 220027, 220032, 220040, 220041, 220042, 220050, 220061, 220066, 220070, 220073, 220075, 220077, 220082, 220083, 220090, 220095, 220101, 220106, 220108, 220113, 220119, 220121, 220122, 220123, 220128, 220139, 220141, 220142, 220143, 220144, 220146, 220149, 220150, 220155, 220156, 220158, 220159, 220161, 220166, 220168, 220169, 220170, 220171, 220173, 220174, 220176, 220179, 220180, 220181, 220182, 220186, 220188, 220190, 220192, 220194, 220195, 220199, 220202, 220206, 220207, 220208, 220209, 220210, 220212, 220214, 220215, 220216, 220223, 220311, 220312, 220313, 220314, 220317, 220320, 220321, 220322, 220323, 220324, 220326, 220327, 220328, 220329, 220333, 220334, 220338, 220342, 220355, 220356, 220357, 220358, 220365, 220371, 220372, 220388, 220390, 220395, 220400, 220405, 220406, 220413, 220642, 220648, 220661, 220663, 220665, 220670, 220676, 220683, 220687, 220689, 220691, 220693, 220695, 220696, 220697, 220700, 220701, 220713, 220714, 220715, 220716, 220721, 220724, 220726, 220728, 220732, 220736, 220739, 220740, 220742, 220744, 220745, 220748, 220749, 220750, 220751, 220752, 220755, 220758, 220761, 220764, 220767, 220775, 220778, 220781, 220784, 220785, 220786, 220794, 220796, 220798, 220803, 220809, 220815, 220816, 220818, 220821, 220827, 220829, 220832, 220833, 220834, 220837, 220842, 220852, 220863, 220867, 220868, 220869, 220871, 220872, 220874, 220878, 220880, 220881, 220883, 220885, 220886, 220887, 220893, 220899, 220902, 220903, 220908, 220910, 220912, 220914, 220918, 220921, 220923, 220924, 220925, 220927, 220931, 220932, 220939, 221478, 221479, 221486, 221489, 221490, 221491, 221495, 221499, 221502, 221509, 221519, 221526, 221527, 221528, 221535, 221537, 221538, 221540, 221542, 221545, 221547, 221548, 221550, 221554, 221555, 221556, 221557, 221558, 221559, 221560, 221563, 221567, 221568, 221574, 221578, 221579, 221587, 221588, 221590, 221592, 221593, 221594, 221596, 221598, 221608, 221610, 221611, 221620, 221622, 221647, 221651, 221655, 221656, 221657, 221658, 221661, 221666, 221667, 221668, 221670, 221673, 221679, 221685, 221686, 221688, 221691, 221692, 221694, 221734, 221740, 221743, 221748, 221749, 221750, 221753, 221759, 221761, 221762, 221765, 221772, 221776, 221781, 221790, 221793, 221796, 221816, 221818, 221825, 221828, 221829, 221830, 221831, 221858, 221860, 221869, 221872, 221878, 221882, 221892, 221896, 221898, 221901, 221905, 221910, 221913, 221914, 221916, 221918, 221920, 221922, 221927, 221929, 221936, 221937, 221945, 221948, 221959, 221962, 221973, 221974, 221985, 221987, 221988, 221995, 222002, 222003, 222015, 222031, 222033, 222040, 222068, 222075, 222097, 222117, 222136, 222138, 222139, 222145, 222160, 222163, 222167, 222173, 222176, 222188, 222191, 222193, 222195, 222205, 222209, 222215, 222216, 222220, 222228, 222241, 222245, 222256, 222261, 222262, 222267, 222276, 222280, 222287, 222293, 222294, 222296, 222299, 222305, 222309, 222314, 222328, 222329, 222333, 222334, 222342, 222352, 222353, 222370, 222378, 222380, 222381, 222399, 222402, 222407, 222411, 222414, 222416, 222422, 222424, 222438, 222439, 222446, 222450, 222451, 222456, 222471, 222474, 222477, 222478, 222484, 222485, 222489, 222492, 222502, 222505, 222510, 222511, 222516, 222518, 222524, 222530, 222536, 222537, 222538, 222543, 222544, 222548, 222550, 222551, 222553, 222557, 222560, 222564, 222565, 222569, 222572, 222585, 222587, 222590, 222591, 222593, 222596, 222597, 222600, 222601, 222603, 222606, 222618, 222634, 222642, 222682, 222686, 222691, 222703, 222712, 222750, 222756, 222763, 222780, 222781, 222783, 222786, 222794, 222798, 222802, 222804, 222809, 222811, 222815, 222824, 222827, 222828, 222831, 222832, 222840, 222865, 222867, 222884, 222886, 222887, 222890, 222903, 222914, 222933, 222942, 222947, 222955, 222962, 222964, 222969, 222985, 222986, 222997, 222998, 222999, 223002, 223008, 223018, 223021, 223029, 223030, 223049, 223050, 223074, 223075, 223076, 223086, 223093, 223099, 223100, 223113, 223114, 223115, 223117, 223118, 223137, 223139, 223144, 223151, 223161, 223172, 223181, 223183, 223184, 223195, 223204, 223208, 223210, 223218, 223231, 223234, 223236, 223243, 223249, 223252, 223253, 223254, 223257, 223259, 223260, 223264, 223268, 223277, 223278, 223283, 223290, 223295, 223296, 223297, 223310, 223312, 223314, 223329, 223334, 223336, 223394, 223641, 223922, 224871, 225461, 225570, 225689, 226817, 226866, 227102, 227103, 227120, 227121, 227125, 227132, 227140, 227143, 227149, 227150, 227152, 227155, 227163, 227166, 227169, 227171, 227175, 227178, 227181, 227191, 227194, 227197, 227209, 227211, 227224, 227226, 227229, 227230, 227233, 227235, 227237, 227241, 227242, 227243, 227247, 227254, 227262, 227273, 227278, 227279, 227286, 227289, 227293, 227299, 227303, 227305, 227308, 227309, 227317, 227319, 227324, 227330, 227331, 227343, 227345, 227346, 227351, 227352, 227361, 227362, 227366, 227369, 227374, 227376, 227378, 227381, 227382, 227392, 227396, 227398, 227403, 227404, 227409, 227416, 227419, 227421, 227431, 227442, 227446, 227456, 227461, 227463, 227469, 227474, 227475, 227481, 227482, 227490, 227500, 227502, 227505, 227506, 227510, 227511, 227516, 227537, 227544, 227551, 227556, 227558, 227560, 227562, 227563, 227648, 228216, 228230, 228235, 228236, 228237, 228243, 228244, 228247, 228255, 228256, 228257, 228258, 228260, 228263, 228264, 228269, 228277, 228284, 228286, 228287, 228288, 228291, 228300, 228302, 228306, 228307, 228308, 228316, 228317, 228320, 228322, 228332, 228342, 228362, 228364, 228368, 228369, 228375, 228381, 228386, 228394, 228398, 228399, 228401, 228404, 228406, 228407, 228411, 228412, 228417, 228419, 228421, 228422, 228423, 228425, 228435, 228440, 228447, 228449, 228450, 228452, 228455, 228459, 228460, 228481, 228482, 228494, 228501, 228502, 228509, 228510, 228511, 228516, 228518, 228527, 228529, 228530, 228532, 228533, 228542, 228543, 228556, 228559, 228569, 228907, 228911, 228915, 228918, 228919, 228920, 228934, 228935, 228936, 228939, 228946, 228947, 228948, 228951, 228955, 228961, 228969, 228970, 228977, 228988, 228989, 228990, 228992, 228994, 228998, 229003, 229004, 229007, 229010, 229011, 229015, 229016, 229024, 229120, 229126, 229127, 229134, 229139, 229141, 229147, 229152, 229153, 229154, 229155, 229156, 229162, 229163, 229164, 229166, 229168, 229170, 229171, 229173, 229174, 229175, 229179, 229180, 229182, 229183, 229184, 229185, 229186, 229187, 229188, 229189, 229191, 229193, 229195, 229196, 229199, 229208, 229210, 229212, 229213, 229214, 229218, 229220, 229230, 229233, 229234, 229236, 229240, 229241, 229242, 229243, 229244, 229246, 229247, 229249, 229251, 229255, 229262, 229263, 229265, 229266, 229267, 229268, 229269, 229270, 229274, 229275, 229366, 230056, 230057, 230059, 230060, 230061, 230066, 230072, 230073, 230074, 230077, 230081, 230083, 230086, 230090, 230094, 230098, 230099, 230100, 230102, 230106, 230116, 230117, 230120, 230122, 230123, 230124, 230127, 230132, 230136, 230138, 230140, 230146, 230150, 230154, 230156, 230157, 230158, 230160, 230164, 230165, 230167, 230172, 230187, 230189, 230197, 230198, 230199, 230201, 230212, 230213, 230216, 230219, 230220, 230223, 230225, 230226, 230228, 230230, 230231, 230234, 230235, 230236, 230240, 230242, 230244, 230247, 230248, 230250, 230254, 230260, 230263, 230266, 230273, 230275, 230277, 230279, 230280, 230282, 230290, 230297, 230298, 230311, 230319, 230329, 230337, 230340, 230343, 230350, 230351, 230352, 230353, 230355, 230356, 230358, 230360, 230365, 230370, 230377, 230384, 230387, 230388, 230390, 230392, 230394, 230397, 230400, 230402, 230403, 230406, 230408, 230409, 230413, 230414, 230415, 230425, 230429, 230432, 230434, 230438, 230444, 230449, 230453, 230587, 230623, 230810, 231056, 231225, 231227, 231229, 231232, 231234, 231236, 231250, 231252, 231255, 231259, 231261, 231262, 231267, 231275, 231283, 231289, 231291, 231294, 231298, 231304, 231305, 231312, 231319, 231320, 231322, 231325, 231328, 231345, 231348, 231349, 231352, 231354, 231356, 231372, 231376, 231378, 231381, 231383, 231386, 231390, 231405, 231412, 231417, 231419, 231424, 231623, 232075, 232218, 232221, 232222, 232223, 232224, 232225, 232227, 232228, 232229, 232230, 232231, 232236, 232237, 232254, 232255, 232258, 232260, 232264, 232265, 232266, 232267, 232269, 232270, 232273, 232276, 232277, 232281, 232282, 232286, 232287, 232291, 232293, 232294, 232305, 232309, 232314, 232316, 232321, 232325, 232329, 232333, 232334, 232336, 232338, 232339, 232341, 232343, 232347, 232348, 232353, 232358, 232360, 232363, 232365, 232366, 232368, 232372, 232373, 232380, 232383, 232392, 232396, ...

Label field

Details supplied by the agency

Lot, code or applicability

GTIN 00802526559228, Serial numbers: 103410, 200337, 200359, 200704, 201273, 201585, 202131, 203086, 204240, 204255, 204383, 204472, 204532, 204553, 204558, 204581, 204619, 204644, 204658, 204672, 204680, 204704, 204729, 204735, 204748, 204768, 204779, 204855, 204883, 204891, 204907, 204916, 204929, 204934, 204947, 204951, 204957, 204959, 204968, 204985, 205002, 205044, 205073, 205083, 205105, 205130, 205149, 205192, 205199, 205211, 205227, 205233, 205236, 205290, 205360, 205362, 205363, 205408, 205412, 205413, 205415, 205455, 205480, 205543, 205553, 205560, 205585, 205586, 205587, 205625, 205632, 205636, 205672, 205673, 205686, 205688, 205733, 205742, 205767, 205770, 205773, 205782, 205791, 205796, 205797, 205810, 205854, 205855, 205857, 205861, 205863, 205907, 205911, 205920, 205940, 205945, 205946, 205958, 205961, 205965, 205967, 205971, 205975, 205977, 205979, 205989, 205992, 205997, 205998, 206011, 206019, 206033, 206045, 206046, 206049, 206069, 206070, 206074, 206075, 206080, 206090, 206091, 206092, 206095, 206098, 206112, 206115, 206122, 206129, 206138, 206140, 206142, 206146, 206167, 206175, 206184, 206190, 206192, 206195, 206200, 206217, 206219, 206220, 206222, 206225, 206226, 206230, 206233, 206244, 206255, 206263, 206277, 206287, 206294, 206295, 206297, 206299, 206300, 206318, 206320, 206326, 206333, 206342, 206343, 206346, 206373, 206407, 206412, 206415, 206437, 206458, 206473, 206502, 206509, 206533, 206541, 206548, 206551, 206556, 206578, 206699, 206762, 206855, 206959, 207311, 207987, 208185, 208473, 208694, 208876, 209013, 209266, 209386, 209388, 209463, 209618, 209752, 209830, 209963, 210013, 210023, 210032, 210044, 210078, 210177, 210192, 210211, 210252, 210338, 210390, 210401, 210493, 210500, 210570, 210685, 210730, 210744, 210773, 210780, 210787, 210814, 210852, 210874, 210917, 210928, 210989, 211000, 211051, 211073, 211099, 211107, 211150, 211157, 211199, 211258, 211266, 211271, 211290, 211333, 211351, 211364, 211401, 211404, 211409, 211415, 211466, 211493, 211496, 211521, 211536, 211544, 211560, 211578, 211658, 211659, 211694, 211697, 211735, 211794, 211806, 211816, 211838, 211842, 211860, 211863, 211899, 211901, 211908, 211937, 211941, 211944, 211958, 211963, 211964, 211966, 211976, 211977, 211983, 211984, 211987, 212013, 212035, 212039, 212051, 212059, 212060, 212062, 212068, 212071, 212077, 212079, 212080, 212087, 212088, 212091, 212101, 212107, 212128, 212131, 212136, 212138, 212148, 212149, 212165, 212168, 212179, 212182, 212184, 212190, 212192, 212193, 212198, 212201, 212207, 212221, 212248, 212255, 212261, 212283, 212470, 212556, 212562, 212640, 212796, 212857, 212937, 213150, 213153, 213166, 213173, 213217, 213242, 213326, 213361, 213362, 213370, 213382, 213399, 213490, 213501, 213512, 213522, 213567, 213634, 213663, 213700, 213739, 216402, 216680, 216880, 217526, 217806, 218042, 218214, 218459, 218609, 218658, 218692, 218767, 218857, 218926, 218967, 219037, 219178, 219207, 219463, 219522, 219580, 219645, 219663, 219681, 219688, 219701, 219706, 219711, 219721, 219722, 219731, 219748, 219756, 219757, 219782, 219786, 219802, 219822, 219835, 219843, 219844, 219852, 219863, 219873, 219881, 219888, 219889, 219894, 219897, 219920, 219924, 219932, 219936, 219937, 219940, 219955, 219958, 219961, 219967, 219971, 219972, 219976, 219980, 219988, 219997, 220002, 220009, 220010, 220013, 220015, 220016, 220018, 220019, 220021, 220027, 220032, 220040, 220041, 220042, 220050, 220061, 220066, 220070, 220073, 220075, 220077, 220082, 220083, 220090, 220095, 220101, 220106, 220108, 220113, 220119, 220121, 220122, 220123, 220128, 220139, 220141, 220142, 220143, 220144, 220146, 220149, 220150, 220155, 220156, 220158, 220159, 220161, 220166, 220168, 220169, 220170, 220171, 220173, 220174, 220176, 220179, 220180, 220181, 220182, 220186, 220188, 220190, 220192, 220194, 220195, 220199, 220202, 220206, 220207, 220208, 220209, 220210, 220212, 220214, 220215, 220216, 220223, 220311, 220312, 220313, 220314, 220317, 220320, 220321, 220322, 220323, 220324, 220326, 220327, 220328, 220329, 220333, 220334, 220338, 220342, 220355, 220356, 220357, 220358, 220365, 220371, 220372, 220388, 220390, 220395, 220400, 220405, 220406, 220413, 220642, 220648, 220661, 220663, 220665, 220670, 220676, 220683, 220687, 220689, 220691, 220693, 220695, 220696, 220697, 220700, 220701, 220713, 220714, 220715, 220716, 220721, 220724, 220726, 220728, 220732, 220736, 220739, 220740, 220742, 220744, 220745, 220748, 220749, 220750, 220751, 220752, 220755, 220758, 220761, 220764, 220767, 220775, 220778, 220781, 220784, 220785, 220786, 220794, 220796, 220798, 220803, 220809, 220815, 220816, 220818, 220821, 220827, 220829, 220832, 220833, 220834, 220837, 220842, 220852, 220863, 220867, 220868, 220869, 220871, 220872, 220874, 220878, 220880, 220881, 220883, 220885, 220886, 220887, 220893, 220899, 220902, 220903, 220908, 220910, 220912, 220914, 220918, 220921, 220923, 220924, 220925, 220927, 220931, 220932, 220939, 221478, 221479, 221486, 221489, 221490, 221491, 221495, 221499, 221502, 221509, 221519, 221526, 221527, 221528, 221535, 221537, 221538, 221540, 221542, 221545, 221547, 221548, 221550, 221554, 221555, 221556, 221557, 221558, 221559, 221560, 221563, 221567, 221568, 221574, 221578, 221579, 221587, 221588, 221590, 221592, 221593, 221594, 221596, 221598, 221608, 221610, 221611, 221620, 221622, 221647, 221651, 221655, 221656, 221657, 221658, 221661, 221666, 221667, 221668, 221670, 221673, 221679, 221685, 221686, 221688, 221691, 221692, 221694, 221734, 221740, 221743, 221748, 221749, 221750, 221753, 221759, 221761, 221762, 221765, 221772, 221776, 221781, 221790, 221793, 221796, 221816, 221818, 221825, 221828, 221829, 221830, 221831, 221858, 221860, 221869, 221872, 221878, 221882, 221892, 221896, 221898, 221901, 221905, 221910, 221913, 221914, 221916, 221918, 221920, 221922, 221927, 221929, 221936, 221937, 221945, 221948, 221959, 221962, 221973, 221974, 221985, 221987, 221988, 221995, 222002, 222003, 222015, 222031, 222033, 222040, 222068, 222075, 222097, 222117, 222136, 222138, 222139, 222145, 222160, 222163, 222167, 222173, 222176, 222188, 222191, 222193, 222195, 222205, 222209, 222215, 222216, 222220, 222228, 222241, 222245, 222256, 222261, 222262, 222267, 222276, 222280, 222287, 222293, 222294, 222296, 222299, 222305, 222309, 222314, 222328, 222329, 222333, 222334, 222342, 222352, 222353, 222370, 222378, 222380, 222381, 222399, 222402, 222407, 222411, 222414, 222416, 222422, 222424, 222438, 222439, 222446, 222450, 222451, 222456, 222471, 222474, 222477, 222478, 222484, 222485, 222489, 222492, 222502, 222505, 222510, 222511, 222516, 222518, 222524, 222530, 222536, 222537, 222538, 222543, 222544, 222548, 222550, 222551, 222553, 222557, 222560, 222564, 222565, 222569, 222572, 222585, 222587, 222590, 222591, 222593, 222596, 222597, 222600, 222601, 222603, 222606, 222618, 222634, 222642, 222682, 222686, 222691, 222703, 222712, 222750, 222756, 222763, 222780, 222781, 222783, 222786, 222794, 222798, 222802, 222804, 222809, 222811, 222815, 222824, 222827, 222828, 222831, 222832, 222840, 222865, 222867, 222884, 222886, 222887, 222890, 222903, 222914, 222933, 222942, 222947, 222955, 222962, 222964, 222969, 222985, 222986, 222997, 222998, 222999, 223002, 223008, 223018, 223021, 223029, 223030, 223049, 223050, 223074, 223075, 223076, 223086, 223093, 223099, 223100, 223113, 223114, 223115, 223117, 223118, 223137, 223139, 223144, 223151, 223161, 223172, 223181, 223183, 223184, 223195, 223204, 223208, 223210, 223218, 223231, 223234, 223236, 223243, 223249, 223252, 223253, 223254, 223257, 223259, 223260, 223264, 223268, 223277, 223278, 223283, 223290, 223295, 223296, 223297, 223310, 223312, 223314, 223329, 223334, 223336, 223394, 223641, 223922, 224871, 225461, 225570, 225689, 226817, 226866, 227102, 227103, 227120, 227121, 227125, 227132, 227140, 227143, 227149, 227150, 227152, 227155, 227163, 227166, 227169, 227171, 227175, 227178, 227181, 227191, 227194, 227197, 227209, 227211, 227224, 227226, 227229, 227230, 227233, 227235, 227237, 227241, 227242, 227243, 227247, 227254, 227262, 227273, 227278, 227279, 227286, 227289, 227293, 227299, 227303, 227305, 227308, 227309, 227317, 227319, 227324, 227330, 227331, 227343, 227345, 227346, 227351, 227352, 227361, 227362, 227366, 227369, 227374, 227376, 227378, 227381, 227382, 227392, 227396, 227398, 227403, 227404, 227409, 227416, 227419, 227421, 227431, 227442, 227446, 227456, 227461, 227463, 227469, 227474, 227475, 227481, 227482, 227490, 227500, 227502, 227505, 227506, 227510, 227511, 227516, 227537, 227544, 227551, 227556, 227558, 227560, 227562, 227563, 227648, 228216, 228230, 228235, 228236, 228237, 228243, 228244, 228247, 228255, 228256, 228257, 228258, 228260, 228263, 228264, 228269, 228277, 228284, 228286, 228287, 228288, 228291, 228300, 228302, 228306, 228307, 228308, 228316, 228317, 228320, 228322, 228332, 228342, 228362, 228364, 228368, 228369, 228375, 228381, 228386, 228394, 228398, 228399, 228401, 228404, 228406, 228407, 228411, 228412, 228417, 228419, 228421, 228422, 228423, 228425, 228435, 228440, 228447, 228449, 228450, 228452, 228455, 228459, 228460, 228481, 228482, 228494, 228501, 228502, 228509, 228510, 228511, 228516, 228518, 228527, 228529, 228530, 228532, 228533, 228542, 228543, 228556, 228559, 228569, 228907, 228911, 228915, 228918, 228919, 228920, 228934, 228935, 228936, 228939, 228946, 228947, 228948, 228951, 228955, 228961, 228969, 228970, 228977, 228988, 228989, 228990, 228992, 228994, 228998, 229003, 229004, 229007, 229010, 229011, 229015, 229016, 229024, 229120, 229126, 229127, 229134, 229139, 229141, 229147, 229152, 229153, 229154, 229155, 229156, 229162, 229163, 229164, 229166, 229168, 229170, 229171, 229173, 229174, 229175, 229179, 229180, 229182, 229183, 229184, 229185, 229186, 229187, 229188, 229189, 229191, 229193, 229195, 229196, 229199, 229208, 229210, 229212, 229213, 229214, 229218, 229220, 229230, 229233, 229234, 229236, 229240, 229241, 229242, 229243, 229244, 229246, 229247, 229249, 229251, 229255, 229262, 229263, 229265, 229266, 229267, 229268, 229269, 229270, 229274, 229275, 229366, 230056, 230057, 230059, 230060, 230061, 230066, 230072, 230073, 230074, 230077, 230081, 230083, 230086, 230090, 230094, 230098, 230099, 230100, 230102, 230106, 230116, 230117, 230120, 230122, 230123, 230124, 230127, 230132, 230136, 230138, 230140, 230146, 230150, 230154, 230156, 230157, 230158, 230160, 230164, 230165, 230167, 230172, 230187, 230189, 230197, 230198, 230199, 230201, 230212, 230213, 230216, 230219, 230220, 230223, 230225, 230226, 230228, 230230, 230231, 230234, 230235, 230236, 230240, 230242, 230244, 230247, 230248, 230250, 230254, 230260, 230263, 230266, 230273, 230275, 230277, 230279, 230280, 230282, 230290, 230297, 230298, 230311, 230319, 230329, 230337, 230340, 230343, 230350, 230351, 230352, 230353, 230355, 230356, 230358, 230360, 230365, 230370, 230377, 230384, 230387, 230388, 230390, 230392, 230394, 230397, 230400, 230402, 230403, 230406, 230408, 230409, 230413, 230414, 230415, 230425, 230429, 230432, 230434, 230438, 230444, 230449, 230453, 230587, 230623, 230810, 231056, 231225, 231227, 231229, 231232, 231234, 231236, 231250, 231252, 231255, 231259, 231261, 231262, 231267, 231275, 231283, 231289, 231291, 231294, 231298, 231304, 231305, 231312, 231319, 231320, 231322, 231325, 231328, 231345, 231348, 231349, 231352, 231354, 231356, 231372, 231376, 231378, 231381, 231383, 231386, 231390, 231405, 231412, 231417, 231419, 231424, 231623, 232075, 232218, 232221, 232222, 232223, 232224, 232225, 232227, 232228, 232229, 232230, 232231, 232236, 232237, 232254, 232255, 232258, 232260, 232264, 232265, 232266, 232267, 232269, 232270, 232273, 232276, 232277, 232281, 232282, 232286, 232287, 232291, 232293, 232294, 232305, 232309, 232314, 232316, 232321, 232325, 232329, 232333, 232334, 232336, 232338, 232339, 232341, 232343, 232347, 232348, 232353, 232358, 232360, 232363, 232365, 232366, 232368, 232372, 232373, 232380, 232383, 232392, 232396, ...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date: Oct 22, 2025
Recall initiation date: Aug 20, 2025
Center classification date: Oct 10, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records